Assess Safety and Efficacy of VAD044 in HHT Patients

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase 1b proof of concept study, randomised, placebo controlled, double blind, multicentre study is to asssess safety and efficacy of 2 doses of VAD044 in adult HHT patients

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vaderis Therapeutics AG

Criteria

Inclusion Criteria:

• diagnosis of HHT by the Curaçao criteria

• several epistaxis/week

• anaemia

• COVID-19 vaccination

Exclusion Criteria:

• Type 1 diabetes or uncontrolled type II diabetes (insulin or non-insulin dependent)

• Active COVID-19 infection

• active uncontrolled infection or known to be serologically positive for HIV, Hep B, Hep C infection

• Recent procedures on nasal telangiectases (<6 weeks)

• Requiring therapeutic anticoagulation

• Use of drugs with anti-angiogenic properties in the past 8 weeks

• laboratory abnormalities